During the week of May 6, 2019, the Patent Trial and Appeal Board (“the Board”) issued four decisions in TC 1600. In those, the Board instituted two inter partes reviews (“IPR”) and one post grant review (“PGR”), but refused to institute one IPR.
Neptune Generics LLC v. Aventis Pharma S.A., Case IPR2019-00136 (Decision Denying Institution Entered May 6, 2019). In this case, the Board exercised its discretion under 35 U.S.C. § 325(d) to deny institution of an IPR. The petitioner, Neptune Generics LLC (“Neptune”), requested review of two claims of Patent No. 5,847,170 (“the ’170 patent”) covering a specific compound that is active against treatment-resistant tumors, and pharmaceutical compositions with that compound. IPR2019-00136, Paper 15 at 4–5, 9. Neptune raised two obviousness grounds, one based on three references and another based on those same references with an additional one. Id. at 9. Neptune argued the prior-art treatment paclitaxel would have been chosen as the lead compound (id. at 27) and the references rationalized modifications needed to reach the claimed compound (id. at 31).
The Board previously denied a 2016 IPR petition on the same two claims of the ’170 patent. Id. at 3, 20–23. Instead of Neptune’s lead compound, paclitaxel, the earlier petitioner had asserted an analogue of paclitaxel disclosed in a reference that Neptune included in its combinations. Id. at 21. In the earlier proceeding, the Board found there was no suggestion in the petitioner’s asserted references to modify the lead compound, and that the challenge was based on hindsight. Id. at 23.
At the time of Neptune’s petition, the ’170 patent was also subject to co-pending district court litigation in which a court had rejected an obviousness challenge. Id. at 23. The court chose paclitaxel (or docetaxel) as lead compound and heard testimony on Neptune’s three main references. Id. at 24. But according to the court, that obviousness case was based on hindsight, motivation for the needed modifications was not established, and secondary considerations supported the patentee. Id. at 25.
Based on these two proceedings, the Board denied Neptune’s petition under § 325(d). Id. at 37. The Board was unpersuaded that the different lead compound in the earlier IPR petition sufficiently distinguished that case from this one. Id. at 31. Paclitaxel (Neptune’s lead compound) was a precursor of the earlier petitioner’s lead compound, and Neptune pressed for modifications that resulted in the earlier lead compound before reaching the invention. Id. The references in both proceedings were substantially similar according to the Board, and Neptune relied on its references for the same teaching as the earlier petitioner. Id. Neptune tried to distinguish the references based on a reference in the earlier case’s teaching of a modification that led away from the claimed compound. Id. at 32–33. But the Board was unpersuaded the teaching-away issue distinguished the two challenges because Neptune had made the same argument as the earlier petitioner. Id. at 33. Moreover, while Neptune made motivation arguments not raised in the earlier petition, the Board concluded those arguments were inadequately developed. Id. at 34. Finally, the Board ruled that the stage and overlap of the related court litigation favored a discretionary denial. Id. at 37.
Grünenthal GmbH v. Antecip Bioventures II LLC, Case PGR2019-00003 (Decision Granting Institution Entered May 7, 2019). Grünenthal GmbH (“Petitioner”) sought PGR of all claims of Patent No. 9,867,839 (“the ’839 patent”). The patent owner, Antecip Bioventures II LLC, did not file a preliminary response, and the Board instituted PGR on all grounds. PGR2019-00003, Paper 7 at 2.
The claims of the ’839 patent covered methods of treating joint pain with neridronic acid (claims 1-14) or zoledronic acid (claims 15-30), two bisphosphonate compounds. Id. at 3–5. All claims required a minimum pain intensity as measure by one of two pain scales. Id. at 4–5. The neridronic acid claims additionally required joint pain for “at least 3 months”; the zoledronic acid claims additionally required oral administration of the treatment at a specific monthly dosage range. Id.
After finding the ’839 patent eligible for PGR and adopting Petitioner’s skill level and claim construction proposals, the Board rejected two grounds against the neridronic acid claims based on § 112, a written description and enablement ground. Id. at 9–17. While the specification contained no disclosure pertaining to the requirement of pain for “at least three months,” the Board explained, the originally filed claim itself provided adequate written support. Id. at 12–14. Even though the specification included no examples of treatment with neridronic acid and disclosed only broad ranges of possible doses, the Petitioner had not established “anything other than straightforward, routine, and empirical” experimentation and failed to “account adequately for the general knowledge of the ordinarily skilled artisan” as demonstrated by the prior art. Id. at 16.
The Board, however, was persuaded that the Petitioner was likely to demonstrate the claims of the ’839 patent were unpatentable with respect to four obviousness grounds. The Board found the first ground, which was directed to the neridronic acid claims and was based on a primary reference describing neridronic acid treatment of chronic regional pain syndrome (“CRPS”) with no explicit disclosure of “joint pain,” was likely to succeed. Id. 20–21. The Board also found two other grounds against the neridronic acid claims were reasonably likely to succeed because the combination of references disclosed neridronic acid treatment of joint pain and “at least 3 months” of pain requirement in connection with a different bisphosphonate. Id. at 23–25. Finally, for the zoledronic acid claims, the Board accepted the fourth obviousness ground, which was based on two references disclosing zoledronic acid treatment of CRPS (with no disclosure of oral formulations or treatment of joint pain), a reference describing oral formulations of zoledronic acid (with no disclosure of actual treatment), and the reference connecting CRPS to knee pain. Id. at 28–31. The Board accordingly instituted PGR on all grounds. Id. at 32–33.
Merck Sharp & Dohme Corp. v. GlaxoSmithKline Biologicals SA, Case IPR2019-00230, IPR2019-00241 (Decisions Granting Institution Entered May 9, 2019): The Board instituted two related inter partes reviews sought by petitioner Merck Sharp & Dohme Corp. (“Merck”) against patent owner GlaxoSmithKline Biologicals SA (“Glaxo”). Both petitions involved claims 1, 2, 4–14, and 16–21 of Patent No. 9,422,345 (“the ’345 patent”). IPR2019-00230, Paper No. 8 at 2; IPR2019-00241, Paper No. 8 at 2.
The ’345 patent related to the expression of bacterial toxins, in particular diphtheria toxins. ’345 Patent at 1:9–10. The ’345 patent also described processes for the expression and manufacture of bulk cultures of the toxins as well as polynucleotides and polypeptides that can be used or produced during the processes. Id. at 1:10–15.
Merck concurrently filed IPR2019-00230 and IPR2019-00241 and contended in both that the challenged claims were unpatentable under 35 U.S.C. §§ 102 and 103 but on different groundsIPR2019-00230, Paper No. 8 at 2, 5; IPR2019-00241, Paper No. 8 at 2, 5. The petitions also differed because, in IPR2019-00241, Merck argued that the ’345 patent could not claim priority to an earlier filed application due to lack of written description support, an argument not pursued in IPR2019-00230. IPR2019-00230, Paper No. 8 at 12–13; IPR2019-00241, Paper No. 8 at 12–13.
In IPR2019-00230, Merck asserted all the challenged claims were anticipated by or obvious over prior art references under 102(b). IPR2019-00230, Paper No. 8 at 5–6, 12–13. Specifically, Merck asserted that claims 1, 2, 18, 19, and 21 were anticipated by U.S. Patent Application Number 2003/0157093 (“Neville”). Id. at 14. In one example described in Neville, a polynucleotide construct related to diphtheria contained a 5′ signal sequence portion and a 3′ toxin portion that encoded an amino acid sequence that was 99.6% identical to SEQ ID NO: 32 in the ’345 patent. Id. at 14–15. The 5′ portion of the polynucleotide sequence also encoded a PelB leader (signal) sequence. Id. at 15. Accordingly, the Board determined that Merck established a reasonable likelihood that Neville anticipated claims 1, 2, 18, 19, and 21. Id. at 16.
With respect to claims 4–14, 16, 17, and 20, Merck asserted an obviousness argument based on Neville in view of an article from Huber et al. (“Huber”). Id. at 6. Merck argued that “Huber demonstrated that nine of the thirteen signal sequences recited in the ’345 patent claims, including FlgI (which is present in each of claims 4–14, 16–17 and 20), are capable of directing transport of a normally cytoplasmic polypeptide (thioredoxin) to the E. coli periplasm.” Id. at 17 (citation omitted). Merck further explained that the teachings of Neville and Huber “would have provided POSAs with a reasonable expectation that combining the teaching of Neville and Huber would successfully produce the polynucleotides of claims 4–14, 16–17 and 20.” Id. at 18 (citation omitted). The Board determined that Merck established a reasonable likelihood that claim 6 was obvious over Neville in view of Huber. Id.
Merck made several additional anticipation and obviousness arguments that the Board did not substantively review but did include in their institution decision. Id. at 19 (citing SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018)).
In IPR2019-00241, Merck argued that the ’345 patent could not claim priority back to an earlier filed application (GB App No. 0917647) because that foreign application contained no written description support for certain claim terms in the ’345 patent. IPR2019-00241, Paper No. 8 at 12–13. The Board determined the foreign application did provide written description support for one of the disputed claim terms, but not for another claim term. Id. at 15, 18. The Board found that “the earliest effective filing date of the challenged claims of the ’345 patent [wa]s October 7, 2010,” which was nearly one year after the October 8, 2009 filing date of the foreign priority application. Id. at 21.
Merck then asserted that claims 1, 2, 18–19, and 21 were anticipated by WO2011/123139 (“Retallack”) and U.S. Patent No. 9,580,719 (“Retallack-719”) under 35 U.S.C. § 102(e). Id. at 5. Retallack was filed on April 9, 2010, and Retallack-719 was filed on October 30, 2009. Id. According to Merck, Retallack disclosed nucleotide sequences encoding a protein fused to a signal that directed its transfer to the periplasm. Id. at 23. The polynucleotides contained a 3′ toxin portion encoding the protein and a 5′ signal sequence encoding a secretion leader. Id. Merck also argued that the amino acid sequence of the protein was 100% identical to SEQ ID NO: 32 of the ’345 patent. Id. The Board held that Merck established a reasonable likelihood of prevailing on its assertion that Retallack anticipated claims 1, 2, 18, 19, and 21 of the ’345 patent. Id. at 24.
Merck also asserted that Retallack in combination with Huber, as described above, rendered claims 4–14, 16, 17, and 20 obvious. Id. The Board concluded that Merck established a reasonable likelihood of prevailing with respect to this ground as well. Id. at 26.
During the week of May 13-17, 2019, the Patent Trial and Appeal Board (“Board”) issued three decisions instituting IPR in Tech Center 1600.
Amneal Pharmaceuticals LLC v. Almirall, LLC, IPR2019-00207 (Decision Instituting IPR Entered May 10, 2019)
The Board granted institution on Amneal Pharmaceuticals LLC’s (“Petitioner”) petition, which challenged as unpatentable all claims of U.S. Patent No. 9,517,219 B2 (“the ’219 patent”) assigned to Almirall, LLC (“Patent Owner”). Petitioner challenged claims 1–8 on two grounds of obviousness. IPR2019-00207, Paper 13 (“’207 IPR”) at 6.
The ’219 patent relates to treatment for acne vulgaris or rosacea by administering a compound including dapsone, diethylene glycol, acrylamide/sodium acryloyldimethyl taurate copolymer (commercial name “Sepineo P 600”), and water, but excluding adapalene. The ’219 patent discloses that diethylene glycol “is a solubilizer for dapsone, thereby allowing compositions to be prepared with increased solubilized concentrations of dapsone.” ’207 IPR at 4. Additionally, the ’219 patent discloses that using “a polymeric builder minimizes the intensity of yellowing of the composition” caused by the increased solubility of dapsone in diethylene glycol and “influences dapsone crystallization” which improves aesthetics by reducing particle size minimizing a “gritty” feeling when applied. Id. (quoting ’219 patent at 2:54-61).
Both obviousness grounds asserted by Petitioner relied on WO 2009/061298 A1 (“Garrett ’298”) and a second reference—WO 2010/072958 A2 (“Nadau-Fourcade”) in Ground 1 and an article by Bonacucina et al. (“Bonacucina”) in Ground 2. Patent Owner argued that the Board should deny institution under 35 U.S.C. §§ 314(a) and 325(d).
After analyzing the General Plastic factors,[1] ’207 IPR at 10-13, the Board instituted review even though some 35 U.S.C. § 314(a) factors “e.g., factor 2 (asserted prior art was known), factor 3 (related IPR preliminary response filed and IPR instituted), and factor 4 (nearly 9 months’ time elapsed), may weigh in favor of Patent Owner’s position for discretional denial[.]” Id. at 12. The Board also found that review was proper under 35 U.S.C. § 325(d) after weighing the Becton factors.[2] ’207 IPR at 13-20. The Board reasoned that while Garrett ’298 was considered during prosecution, it was not a primary focus in the Examiner’s rejections, the Examiner cited it for different teachings, and neither secondary reference was relied on by the Examiner. Id. at 13-16. The Board also observed that the claims were allowed only after Patent Owner submitted evidence of unexpected results, but the Board found flaws with the declaration cited during prosecution to establish unexpected results. Id. at 17-20.
After rejecting Patent Owner’s arguments under sections 314(a) and 325(d), the Board concluded that Petitioner demonstrated a reasonable likelihood of success on the merits. Accordingly, the Board granted institution on both grounds. Id. at 21-25.
Foundation Medicine, Inc. v. Caris MPI, Inc., IPR2019-00166 and-00203 (Decisions Instituting IPR Entered May 14, 2019)
The Board granted institution of Foundation Medicine, Inc.’s (“Petitioner”) two petitions, which challenged all claims of U.S. Patent No. 9,292,660 B2 (“the ’660 patent”), assigned to Caris MPI, Inc. (“Patent Owner”), on obviousness grounds.
The ’660 patent relates to methods and system for using molecular profiling to identify treatments for individuals. See, e.g., IPR2019-00166, Paper 12 (“’166 IPR”) at 3. The patent discloses that molecular profiling analysis can provide more informed and effective personalized treatment options, which can result in improved patient care and enhanced treatment outcomes. Id. The ’660 patent further discloses a system that uses molecular profiling of a patient’s biological specimen to determine individualized medical intervention. Id. at 3-4. The system includes, among other things, an application program stored in a memory that is accessible by a processor, internal databases, and external databases. Id. at 5. The challenged claims are directed to a system for generating a report identifying a therapeutic agent for an individual with lung cancer. Id. at 5-6; see also IPR2019-00203, Paper 12 at 5-6.
Petitioner argued that, under their broadest reasonable interpretation, the claims would have been obvious over a combination of several prior art references.
Patent Owner challenged the status of an asserted prior art reference (Illumina) as a printed publication. ’166 IPR at 14-18; IPR2019-00203, Paper 12 at 15-19. The Board found that, at the institution stage, Petitioner had made a “threshold showing” that the disputed reference was publicly accessible prior to the effective filing date of the challenged patent for the following reasons: (1) the reference itself bears indicia that it was likely published, including a publication date and a publication number; (2) the reference is identified as a “technical bulletin” akin to a product catalog, which is the type of document intended for public dissemination, and it bears no designations, such as “draft” or “confidential” that might suggest that it was not intended for public distribution; (3) and the declaration of the Internet Archive’s Office Manager attested that the publication was archived by the Wayback Machine prior to the effective filing date, thereby confirming that it was publicly available. See, e.g., ’166 IPR at 15-16.
Because Patent Owner did not address the substance of Petitioner’s unpatentability arguments, the Board found that Petitioner had demonstrated a reasonable likelihood of prevailing with respect to the claims of the ’660 patent. Accordingly, the Board granted institution on all grounds of the petitions. See, e.g., id. at 21-22.
[1] General Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357, slip op. at 15 (PTAB Sept. 6, 2017) (Paper 19) (precedential).
[2] Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586, slip op. at 17–18 (PTAB Dec. 15, 2017) (Paper 8) (informative).
During the week ending May 31, 2019, the Board issued four decisions in Technology Center 1600: three decisions instituting inter partes review (IPR) and one decision denying IPR, all styled Foundation Medicine, Inc. v. Caris MPI, Inc. The decisions are summarized as follows:
IPR2019-00164 (Decision—Institution of Inter Partes Review May 30, 2019); IPR2019-00165 (Decision Denying Institution of Inter Partes Review May 30, 2019); IPR2019-00170 (Decision—Institution of Inter Partes Review May 30, 2019); IPR2019-00171 (Decision—Institution of Inter Partes Review May 30, 2019). Petitioner Foundation Medicine, Inc. challenged the patentability of claims 1-14 of U.S. Patent No. 8,880,350 (“the ’350 patent”), claims 1-14 of U.S. Patent No. 9,092,392 (“the ’392 patent”), claims 1-14 of U.S. Patent No. 9,372,193 (“the ’193 patent”), and claims 1-14 of U.S. Patent 9,383,365 (“the ’365 patent”) as being obvious under 35 U.S.C. § 103(a). IPR2019-00164 at 2; IPR2019-00165 at 2; IPR2019-00170 at 2; IPR2019-00171 at 2, respectively. For the ’350, ’193, and ’365 patents, Petitioner asserted three grounds of unpatentability: claims 1-14 would have been obvious over Lu and Illumina; claims 2 and 3 would have been obvious over Lu, Illumina, and Muraca; and claims 7, 11, and 12 would have been obvious over Lu, Illumina, and McDoniels-Silvers. IPR2019-00164 at 8; IPR2019-00170 at 8; IPR2019-00171 at 8, respectively. Petitioner also asserted claims 1-14 of the ’392 patent would have been obvious over Von Hoff, Sjöblom, and Bardelli. IPR2019-00165 at 8.
The ’350, ’392, ’193, and ’365 patents relate to “a ‘system and method for determining individualized medical intervention for a particular disease state,’ such as cancer, that ‘includes the molecular profiling of a biological sample from the patient.’” See IPR2019-00164 at 3; IPR2019-00165 at 3; IPR2019-00170 at 3; IPR2019-00171 at 3, respectively. The claims of the ’350, ’193, and ’365 patents are directed to “cancer” generally (i.e., “[a] system for generating a report identifying at least one therapeutic agent with cancer”), while the ’392 patent’s claims are specific to “colorectal cancer” (i.e., “[a] system for generating a report identifying at least one therapeutic agent with colorectal cancer.”). See IPR2019-00164 at 6; IPR2019-00165 at 6; IPR2019-00170 at 3; IPR2019-00171 at 3, respectively. The patents differ with respect to the claimed group of molecular targets to be assayed. Id.
’350, ’193, and ’365 patents
Prior to evaluating unpatentability, the Board assessed Patent Owner’s argument that Petitioner failed to establish that Illumina, a technical bulletin prepared by Illumina, Inc., qualified as a prior art publication. See IPR2019-00164 at 15.[1] The Board found Petitioner made the “threshold showing,” required at the institution stage, that the Illumina reference was publicly accessible prior to the effective filing dates of the challenged patents. Id. at 15-16. First, Illumina “bears indicia that it was likely published” because it has a publication date and publication number. Id. at 16. Second, Illumina is the type of document intended for public distribution because it is “a ‘technical bulletin,’ akin to a product catalog” and bears no draft or confidentiality designations. Id. Third, the Board considered additional briefing it allowed for the parties to address a declaration from the Internet Archive’s Office Manager attesting that Illumina was archived by the Wayback Machine prior to the effective filing date of the patents, confirming it was publicly available. Id. at 16-17. Fourth, the Board rejected Patent Owner’s argument that Petitioner made no showing that skilled artisans could have found Illumina on the internet without knowing the exact URL where it was published. Relying on Jazz Pharm., Inc. v. Amneal Pharm., LLC, the Board stated, “the Federal Circuit made clear that ‘neither indexing nor searchability’ was required to determine that an online document was publicly accessible.” Id. at 18 (quoting 895 F.3d 1347, 1356 (Fed. Cir. 2018) (citations omitted)). The Board found skilled artisans would have understood that Illumina, Inc. provides research tools for gene expression assays, which would provide them a reason to review Illumina Inc.’s website where Illumina was available. Id. Finally, the Board explained it would rule in the final written decision on Patent Owner’s remaining arguments regarding whether Petitioner met its ultimate burden of establishing public accessibility. Id.
Regarding patentability of the ’350, ’193, and ’365 patents, the Board determined Petitioner established a reasonable likelihood that it would prevail in showing the claims were unpatentable as obvious over Lu and Illumina; Lu, Illumina, and Muraca; and Lu, Illumina, and McDoniels-Silvers, and instituted IPR of all challenged claims on all three grounds. Id. at 29-31.
’392 patent
Petitioner asserted a different set of references, Von Hoff, Sjöblom, and Bardelli, in its obviousness challenge against the claims of the ’392 patent directed to colorectal cancer. IPR2019-00165 at 8. The Board denied institution, finding that “Petitioner has not shown sufficiently for institution that an ordinarily skilled artisan would have had a reason to combine the prior art to obtain the claimed system wherein the molecular targets comprise BRAF, PIK3CA, EGFR, and PTEN.” Id. at 17. The Board emphasized that “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Id. (quoting Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (emphasis in original)).
The Board primarily took issue with Petitioner’s reliance on Sjöblom for its disclosure of “sequencing the genes BRAF, PIK3CD, EGFR, and PTEN.” Id. at 15. Sjöblom evaluated the sequences of ~13,000 genes, including BRAF, PIK3CD, EGFR, and PTEN, for purposes of analyzing alterations in breast and colorectal cancer; however, only 189 of the genes were found to be “candidate cancer genes” (“CAN genes”), 122 in breast cancers and 69 in colorectal cancers. Id. at 13. The Board found that “Petitioner has not explained adequately for institution why an ordinarily skilled artisan would have had a reason to sequence all 13,000+ genes disclosed in Sjöblom to identify a therapeutic agent for an individual with colorectal cancer.” Id. at 17. The Board noted that “Petitioner does not discuss or mention the CAN genes in its analysis, presumably because none of the CAN genes that Sjöblom identifies for colorectal cancer include the molecular targets recited in claim 1: BRAF, PIK3CA, EGFR, and PTEN.” Id. at 18. The Board stated “[g]iven Sjöblom’s express teaching that only some of the CAN genes may be good targets for therapeutic development, it is not clear on this record why an ordinarily skilled artisan would have taken the path Petitioner alleges, i.e., performing large-scale sequencing of 13,023 genes for an individual.” Id. at 19 (emphasis in original). The Board also found that Petitioner’s expert’s testimony regarding Sjöblom was “conclusory” and that he “ignore[d] the teachings of Sjöblom.” Id. at 19-20. The Board denied institution concluding, “[a]lthough we understand that an ordinarily skilled artisan is a person of ordinary creativity, not an automaton, ‘[w]ithout any explanation as to how or why the references would be combined to arrive at the claimed invention, we are left with only hindsight bias that KSR warns against.’” Id. at 20-21 (quoting Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir. 2017)).
[1] Citations are to IPR2019-00164 because the institution decisions for IPR2019-00164, IPR2019-00170, and IPR2019-00171 are substantially the same.